The observations were made during an inspection of the company’s Monrovia, Calif., facilities earlier this year, where Staar manufactures its intraocular lenses. The warning letter, dated May 21, 2014, was published online on June 26.
Inspectors cited missing design files for the several models of the Visian implantable lenses, insufficient record-keeping of design changes and transfers, lack of risk analysis documentation and inadequate customer complaint management, among others. More than anything else, investigators appeared to cite a lack of documentation and Staar’s failure to turn over necessary files.
Analysts at William Blair called the matter one of "innocent disorganization," saying that the FDA warning shouldn’t affect the company’s operations going forward. Nevertheless, the Law Offices of Howard G. Smith issued a statement this week announcing its intention to investigate "potential claims on behalf of investors," as pertaining to the FDA notice.
The FDA letter gives Staar 15 days to respond with steps that the company has taken to correct the violations.
STAA shares dropped nearly 5% today, trading at $14.21 as of about 11:30 a.m. EST.